Method for diagnosing the function
of intrinsic sphincters

ABSTRACT

A method for treating at least one of the urethral and anal sphincters in a patient includes inducing an involuntary reflex cough event within the patient to determine whether a dysfunction exists in at least one of the urethral and anal sphincters. If a dysfunction is determined to exist, then contracting a muscle located at one of at least the urethral and anal sphincters during an inspiratory phase of respiration.

RELATED APPLICATION(S)

This application is a continuation-in-part application of commonlyassigned U.S. patent application Ser. No. 13/456,841 filed on Apr. 26,2012; and this application claims priority to U.S. provisional patentapplication Ser. No. 61/738,027, filed Dec. 17, 2012, and U.S.provisional patent application Ser. No. 61/756,246, filed Jan. 24, 2013,the disclosures which are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates to initiating an involuntary reflex coughtest for diagnosing physiological abnormalities, and more particularly,to testing and diagnosing at least the urethral sphincter.

BACKGROUND OF THE INVENTION

Commonly assigned U.S. patent application Ser. No. 13/456,841 disclosesa system and method that tests the gastric valve and urethral sphincterin a patient. A contrast agent is administered into the esophagus of apatient followed by inducing an involuntary reflex cough epoch withinthe patient to isolate the gastric valve from the lower esophagealsphincter (LES) and isolate the external urethral sphincter from theinternal urethral sphincter. An imaging sensor detects the flow of thecontrast agent during the involuntary reflex cough epoch and determineswhether stomach reflux occurred indicative of a malfunctioning gastricvalve. A determination is made if urine leakage occurs indicative ofstress urinary incontinence (SUI).

The flow of contrast agent can be detected at the level of the LES usinga fluoroscopic instrument configured to image the contrast agent. Achemo-irritant can induce the involuntary reflex cough epoch using anebulizer. Barium sulfate is a preferred contrast agent that isswallowed by the patient. Typically, the involuntary reflex cough epochis induced following the administration of that contrast agent.

A urinary catheter having a pressure sensor is inserted within thebladder. An EMG is obtained from the involuntary cough activatedintercostals and the data processed from the pressure sensor with theEMG to estimate the severity of the SUI. The EMG can be obtained fromthe paraspinals.

It is desirable if further analysis and treatment of the internalurethral sphincter (IUS) and internal anal sphincter (IAS) areaccomplished by observing the pulmonary inspiration efferents thatillicit a pattern reflex motor response to test and diagnose loweresophageal sphincter (LES) and/or the internal urethral sphincter (IUS).

SUMMARY OF THE INVENTION

This summary is provided to introduce a selection of concepts that arefurther described below in the detailed description. This summary is notintended to identify key or essential features of the claimed subjectmatter, nor is it intended to be used as an aid in limiting the scope ofthe claimed subject matter.

A method for treating at least one of the urethral and anal sphinctersin a patient includes inducing an involuntary reflex cough event withinthe patient to determine whether a dysfunction exists in at least one ofthe urethral and anal sphincters. If a dysfunction is determined toexist, then contracting a muscle located at one of at least the urethraland anal sphincters during an inspiratory phase of respiration.

The method includes detecting changes in intra-abdominal pressure todetermine the inspiratory phase of respiration. The method also includesdetecting movement of the ribs in a patient during inspiration andexpiration for determining the inspiratory phase of respiration. Themethod also includes detecting movement of the ribs using sensors placedat the anterior surface of the medial border of the costal margin ofribs 8, 9 or 10. The muscle may be contracted by applying a current intothe muscle. Electrodes may be implanted on the muscle and applyingcurrent to the electrodes for stimulating the muscle to contract.Control signals may be transmitted to the electrodes to initiateelectrical stimulation from a control unit in communication with theelectrodes. The control unit is embedded in the abdominal wall. Thecontrol signals may be transmitted from the control unit to theelectrodes through either microwires connecting the control unit andelectrodes or wirelessly from the control unit to the electrodes. Amuscle may be activated by a mechanical mechanism on at least one of theurethral or anal sphincters to close the sphincter. Endpoints for ribcage movement may be determined.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention willbecome apparent from the detailed description of the invention whichfollows, when considered in light of the accompanying drawings in which:

FIG. 1 is an anterior view of the human torso showing sensors such astransducers positioned to detect movement of the ribs during inspirationand expiration in accordance with a non-limiting example.

FIG. 2 is an anterior view of the human thoracic skeleton showing thesensors such as transducers to detect movement of the ribs duringinspiration and expiration in accordance with a non-limiting example.

FIG. 3 is a medial view of a female pelvis showing sensors astransducers, electrodes and a processor as part of a receiver inaccordance with the non-limiting example.

FIG. 4 is a medial view of a female pelvis showing sensors andtransducers to detect inspiration and simulate the electrodes andoperating wirelessly in accordance with a non-limiting example.

FIG. 4A is a flowchart showing a basic sequence of operation.

FIG. 5A are images of the inspiration closure reflex (ICR) and showingthe BFV sequences for barium swallow followed by deep inspiration thatallows barium to enter the stomach.

FIG. 5B is a nerve conduction pathway circuit diagram for theinspiration closure reflex (ICR) showing how intrinsic sphinctertenacity is regulated during inspiration and expiration in accordancewith a non-limiting example.

FIG. 6A are images showing a barium swallow during a breath-hold of apatient and depicting inspiration followed by barium swallow.

FIG. 6B is a nerve conduction pathway circuit diagram to show thephysiology of the breath-hold as in FIG. 6A in accordance with anon-limiting example.

FIG. 7 are images showing the barium swallow during breath-hold inaccordance with a non-limiting example.

FIG. 8A are images showing the laryngeal expiratory reflex which the LESappear patent during the LER cough epoch in accordance with anon-limiting example.

FIG. 8B shows a nerve conduction pathway circuit diagram of thestimulation of laryngeal receptors using the involuntary reflex coughtest.

FIGS. 9A and 9B are graphs showing pressure recordings of the IUS andLES synchronizes with respiration in accordance with a non-limitingexample.

FIG. 10 is a graph showing relative latencies of the IUS and LES withdeep inspiration and expiration in accordance with a non-limitingexample.

FIG. 11 is a graph showing the breath-hold with maintained pressureelevation in the LES and IUS in accordance with a non-limiting example.

FIGS. 12A and 12B are graphs showing the urodynamic tracing of a seriesof forceful voluntary coughs in accordance with a non-limiting example.

FIG. 13 is another nerve conduction pathway circuit diagram showing theinspiration closure reflex in accordance with a non-limiting example.

FIG. 14 is a flowchart illustrating a sequence of steps for isolatingthe gastric valve to assess its function in accordance with anon-limiting example.

FIG. 15 is another flowchart illustrating a sequence of steps forisolating the gastric valve and external urethral sphincter to assesstheir function in accordance with a non-limiting example.

FIG. 16A is a fragmentary view of an example of a kit having componentsfor use with the methodology described relative to FIGS. 14 and 15 inaccordance with a non-limiting example.

FIG. 16B is a view showing a system that includes a patient bed as aplatform and imaging sensor for performing the methodology of FIGS. 14and 15.

FIG. 17 is a simplified plan view of a catheter that can be used forurodynamic and medical diagnostic testing in accordance with anon-limiting example.

FIG. 18 is a simplified plan view of another example of a cathetersimilar to that shown in FIG. 17 that can be used for urodynamic andmedical diagnostic testing in accordance with a non-limiting example.

FIG. 19 shows a urinary continence pad that can be used with urodynamiccatheters of FIGS. 17 and 18.

FIG. 20 is a plan view of an Ng/Og device or catheter that can be usedfor testing for acid reflux.

FIG. 21 is a fragmentary plan view of a handheld processing device thatcan be used in conjunction with various catheters and Ng/Og devices orother catheters and/or nebulizers.

FIG. 22 is a block diagram showing example components of a handheldprocessing device such as shown in FIG. 21.

FIG. 23 is a block diagram showing an outline of the laryngealexpiratory reflex (LER) and results with the intrinsic sphincterdeficiency and esophageal, urinary and fecal continence.

FIGS. 24A and 24B are graphs detailing what occurs during LER withintrinsic sphincter activity (FIG. 24A) and voluntary cough pathways(FIG. 24B).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Different embodiments will now be described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsare shown. Many different forms can be set forth and describedembodiments should not be construed as limited to the embodiments setforth herein. Rather, these embodiments are provided so that thisdisclosure will be thorough and complete, and will fully convey thescope to those skilled in the art.

Commonly assigned U.S. patent application Ser. Nos. 13/456,882 and13/456,841 filed on Apr. 26, 2012, (U.S. Patent Publication Nos.2012/0277583 and 2012/0277547) by the same inventors and which arehereby incorporated by reference in their entirety, disclose system andmethods for testing the gastric valve and urethral sphincter and withanalysis of the lower esophageal sphincter. Further developments,however, have now been made at observing the effect of respiration onintrinsic sphincters such as the lower esophageal sphincter (LES) andinternal urethral sphincter (IUS).

The functions of the lower esophageal sphincter (LES) an internalurethral sphincter (IUS) have now been analyzed during voluntary andinvoluntary respiratory maneuvers. A prospective barium videoflouroscopystudy (BSV) of the LES on four healthy adult men during voluntary cough(VC) was performed together with the laryngeal expiration reflex (LER),breath-hold maneuvers, and normal inspiration. One subject hadfiber-optic pressure catheters placed in the LES and IUS, andelectromyographic recording of the right T7-8 intercostals duringrespiration. The BSV showed closure and relaxation of the LEScorresponding to the inspiration and expiration of VC. The LES waspatent during the LER. There was closure of the LES during the deepinspiration/breath-hold event. Pressure catheters in the LES and IUSshowed increased pressure during inspiration. These observations suggestthat pulmonary inspiration afferents elicit a patterned reflex motorresponse in the LES and IUS, referred to as the inspiration closurereflex (ICR).

Test results have determined there is an Inspiration Closure Reflex(ICR) control of the IUS (Internal Urethral Sphincter). An IAP (Intraabdominal Pressure) transducer has been used for the study and data. Aprocessor is programmed to correlate the IA (Intra abdominal) pressurechanges and the associated duration of each event (as detected by thepressure transducer) with corresponding stimulation of the smooth muscleof the IUS, and/or the striated muscle of the EUS (external urethralsphincter) and/or AS (anal sphincter). Muscle stimulators may beimplanted using trans-urethral or trans-vaginal approaches and connectedto a processor as part of a receiver either directly such as withmicrowires or indirectly such as using wireless communication, forexample, Bluetooth or other wireless communication.

A trans-vaginal approach is favored when a microwire is inserted viasubcutaneous trochar as from the mid-line, suprapubic and inferiorborder of the pubic ramus. Vaginal palpation occurs at the distal end ofthe microwire for a muscle stimulator to the IUS, EUS, and/or AS. Theconfirmation of placement may be accomplished by the use of a urethralpressure catheter. It is possible to palpate the wire passing posteriorto the vagina and palpate its placement adjacent to the AS surroundingthe anus as distal about one inch of the rectum. The AS stimulation isconfirmed by a rectal pressure catheter. The transducer andmicroprocessor may be connected to the stimulator via a wirelessconnector. A power source and electronic stimulator may be proximate tothe targeted sphincter muscles in this system and apparatus.

FIG. 1 shows an anterior view of the human torso at 30. The sensors 32a, 32 b as transducers in this example are positioned to detectmovements of the ribs during inspiration and expiration and are placedat the anterior surface of the medial border of the costal margin ofribs 8, 9 or 10. The sensors 32 a, 32 b in this example are formed astransducers to measure movement. These sensors 32 a, 32 b (either on oretwo) are directly or indirectly connected to a control unit 34 operativeas a controller having a signal receiver/transceiver, which in thisexample is embedded in the subcutaneous fat of the lower quadrant of theabdominal wall. The control unit 34 controls the electrodes 42, 44 (FIG.3) that simulate contraction of the internal urethral sphincter (IUS)and internal anal sphincter during the inspiratory phase of respiration.

FIG. 2 shows an anterior view of the human thoracic skeleton 36. Theosteocartilaginous thoracic cage 36 as illustrated includes the sternum,12 pairs of ribs and associated costal cartilages and 12 thoracicvertebrae and intervertebral discs. The position of the superior domesof the diaphragm is indicated by the line 38. The sensors 32 a, 32 b areconfigured to detect movement of the ribs during inspiration andexpiration and are placed on the anterior surface of the medial borderof the costal margin of ribs 8, 9 or 10 in this example. The sensors 32a, 32 b may be placed either unilaterally or bilaterally.

FIG. 3 is a medial view of the female pelvis 40. A microprocessor ispart of a control unit 34 and implanted in the fatty layer (Camper'sfascia 40 a) or in the deep layer (Scarpa's fascia 40 b) and against thefascia of the external abdominal oblique muscle in the patient's left orright lower abdominal wall. This control unit 34 receives wirelesssignals from the sensors 32 a, 32 b regarding movement of the lower ribcage during inspiration. The control unit 34 will detect the onset ofinspiration and simulate microelectrodes 42, 44 that are implanted inthe respective internal urethral sphincter (IUS) 46 and internal analsphincter (IAS) 48 indicated by the multiple dotted lines on theappropriate sphincter. The control unit 34 is connected to themicroelectrodes 42, 44 (single or as an array of microelectrodes eitherdirectly (via microwire) or indirectly (wireless, radio frequency,Blue-Ray, or similar technology). These pelvic devices as themicroelectronics may close the IUS or IAS either electronically (musclesimulation) or activate mechanical mechanisms that close the IUS and IASwith or without an intervening processor. Microwires 50 if used areplaced using a trochar to tunnel through Camper's fascia 40 a(subcutaneous fat of the abdominal wall) to the superior border of thepubic bone. There is also illustrated the pubis 40 a, urinary bladder 40b, uterus 40 c, vagina 40 d, and rectum 40 e.

FIG. 4 is a medial view of the female pelvis 40. In this case thetransducer as sensors 32 a, 32 b operate wirelessly and transmitwireless signals at the onset of inspiration, and simulate theelectrodes 42, 44 and/or mechanical or electronic IUS or IAS devices(indicated by the multiple dotted lines 42, 44 on the appropriatesphincter). The attached lines represent that the electrodes could beused or other electronic or mechanical devices to close thesesphincters. The electrodes 42, 44 close these sphincters duringinspiration. The electrodes 42, 44 are implanted in or around theinternal urethral sphincter (IUS) 46 and internal anal sphincter (IAS)48. The sensor(s) 32 a, 32 b in this example are connected to thesphincter closure devices and/or either directly (via microwire) orindirectly (wireless, radio frequency, Blue-Ray, or similar technology).These pelvic devices as electrodes 42, 44 or other device may close theIUS or IAS either electronically (muscle simulation) or mechanicallysuch as by pressing inward on the sphincter with or without anintervening processor or control unit.

Displacement of the diaphragm may be detected by one or two sensors 32a, 32 b or other type of transducers, which are implanted at or on themedial costal border of the eighth rib using a trochar device to implantthe small, cylindrical transducers. These motion sensors 32 a, 32 b astransducers detect the movement of the lower rib cage during deepinspiration. This movement of the rib cage during inspiration occurs asa result of contraction of the diaphragm and the corresponding expansionof the thoracic cavity and abdominal cavity. During inspiration, thecostal margins of ribs 8-10 move supero-laterally and the two motionsensors 32 a, 32 b as illustrated in FIG. 4 may detect an increase indistance between the two devices and thereby rib cage expansioncorresponding to inspiration.

It is possible to calibrate the system using a remote control device orcomputer 52 that is linked to the control unit 34 and operative as atransmitter/receiver and may be used to set the inspiration/expirationendpoints of the rib cage movement via transmission of signals wirelessin this example using a transmitter/receiver circuit 52 a in the remotedevice 52. This calibration is performed in the clinical setting by aclinician. The clinician will ask the patient to completely exhale andwill then press a [set] button 52 b on the remote device 52 at the endof complete exhalation. The motion sensors 32 a, 32 b may be directly orindirectly connected to the devices 42, 44 as electrodes in this examplethat close the IUS and/or IAS through muscle contraction, which willcontrol intrinsic sphincter closure based on deep inspiration and theassociated inspiration closure reflex as a normal neurological eventlinked to significant inspiration.

The clinician will ask the patient to deeply inhale (inspiration) andthen press the [set] button 52 b at the end of deep inspiration. Theremote device computer 52 is linked by radio frequency, Blue-Ray orother similar communications link such as to the control unit 34 ordirectly to the sensors 32 a, 32 b and will record theinspiration/expiration endpoints and the associated range of rib cagemovement. The mode of transmission of signals from the motiontransducers 32 a, 32 b is transmitted by, but not limited to, direct orindirect communication connections to the implanted control unit 34,which can also act as a communications receiver for signals from thesensors 32 a, 32 b, and through a transmitter function, initiate one ormore devices that cause: (1) electronic simulation of the IUS and/or IASsmooth muscle, which will contract these smooth muscle sphincters andprevent voiding and/or evacuation through electronic means; or (2)mechanical closure of the IUS and/or IAS, which contract these smoothmuscle sphincters and prevent voiding and/or evacuation; throughmechanical means. There can be direct or indirect connection to amechanical and/or electronic devices, which will close these sphinctersthrough electronic or mechanical means. The closure of these sphinctersby these devices may be synchronized with the inspiration closure reflex(ICR), a normal neurological event, which occurs with deep inspirationand thereby increases intrinsic sphincter tonicity prior to a potentialincrease in intra-abdominal pressure (IAP).

The control unit 34, which is usually implanted, will detect the startof inspiration through the sensors 32 a, 32 b and initiate correspondingsimulation of the microelectrodes or other devices 42, 44 at theinternal urethral sphincter (IUS) 46 and/or internal anal sphincter(IAS) 48 and thereby increase sphincter tonicity. The device operatesthrough its communications circuitry 35. During urinary voiding orevacuation of the bowel, the control unit 34 may be temporarily turnedoff and permit volitional voiding and/or evacuation of the urinarybladder or bowel, respectively. Pressing an ‘on’ button again, resetsthe device to the previous setting for respiration and control ofsphincter tone and allows synchronizing of the devices or electrodes 42,44 with the patient's inspiration.

The description relative to FIGS. 1-4 assist in understanding the ICRand use of the sensors as transducers 32 a, 32 b for diagnosingphysiological conditions. The system will not usually detect phrenicnerve activity and will not usually use devices to stimulate theinferior hypogastric plexus, which innervates, in part, the internalurethral and internal anal sphincters. That type of device would involvea more invasive surgical procedure and it may be more difficult tocontrol the IUS and IAS as the plexus innervates other pelvicstructures.

The process shown relative to FIGS. 1-4 starts (block 60). Theinvoluntary reflex cough test is administered (block 62). Adetermination is made if there is sphincter dysfunction (block 64). Ifnot, then there are no changes made (block 66). If yes, then electrodesare implanted (block 68). The inspiration/expiration endpoints are thencalibrated (block 70). Sphincters are contracted based on the endpointsduring inspiration and expiration (block 72). This process continuesuntil a determination is made that sphincters no longer need to becontracted and the process ends (block 74). It would be rare to have theprocess end since usually a patient will require the treatment over along period of time.

Detection of diaphragmatic contraction is anatomically complicated byits close proximity to adjacent structures. Any implants or electrodesin the diaphragm may damage or injure these structures, e.g., heart,lungs, gastrointestinal tract, abdominal organs, etc., or cause apneumothorax, hemothorax or similar breech of the pleural cavity. Thus,such a device may not be desirable. The system usually will not use adevice to detect electrical activity of the phrenic nerve.

This type of system is more reliable than a phrenic nerve stimulator. Ifneuropathy is the cause of the ICR breakdown, it is possible to assumeall nerves have some degree of ongoing neuropathy, which may get worse.If the phrenic nerve fails to activate the diaphragm, thus causingshorter movements, it may be assumed that the same process occurs withthe Inferior Hypogastric Plexus to the ICR. It is possible to overridethese deficits to the ICR and reset the closure variables, adjustableover time, using a more reliable method than nerve assessment oractivation.

The phrenic and diaphragm may be adequate but the lumbosacral stenosisinjures the nerves that close the IUS. Any closure settings by thisdetection would be different compared to the phrenic nerve and diaphragmfunction. IUS activation is based in this instance on the presentability to activate the diaphragm, reflected by rib movements. If asubject is restricted in inspiration, COPD, arthritis, kyphosis orrestrictive patterns of breathing, the system resets the IUS closuresensitivity to less activation from the ribs. These settings may beindividually customized by the Urologist and may occur in many differentpatterns. Based on the ICR deficit, they are adjustable by the urologistin the clinic or with an urodynamics examination. The adjustment may becompared to other adjustment technologies, e.g., insulin, pain medicineor intrathecal Baclofen pumps. There is an override to void if thesubject cannot relax and possibly deactivate a sensitive ICR setting,similar to a restrictive, kyphotic type patient. Many other options arepossible.

Tunneling for the microwires 50 to the electrodes 42, 44 isstraightforward to the level of the pubis. Connecting a microwire 50 toan electrode 42, 44 (or electrode array arranged on a tape), however,may require another step. It is possible to use a curved trochar orinstrument similar to that used for a supra-pubic urinary bladdersuspension. The wire is connected to the tape when electrodes arecontained on the tape and pulled into place by palpating the placementper vagina. FIG. 4 shows a tape 58 in block format that supports theillustrated electrode array 44. It should be understood that theelectrodes could be single electrodes, an array of electrodes such as ona tape or other support or other configuration.

The electrodes 42, 44 adjacent to the IUS and IAS may require a powersupply and there may not be room for the power supply in the area of thepelvis, but there are improvements in power supply, especially sinceMEMS technology may be used for sensors and power supplies. Theelectrodes 42, 44 as stimulators are small and do not migrate. Anotherconsideration for design and placement is the vascular layout of vesselsand pathway of nerves, which in this area may be problematic.

It may be possible to use sensors 32 a, 32 b that are programmed to workwith each other and the transponder devices such as the electrodes 42,44 by movement changes. It is possible to activate the electrodes 42, 44without wire placements. Electrodes may also be activated by sensorsdirectly attached to them so that there are no wires and thesensors/electrodes are formed as integrated units. Possiblecommunication linkages include Bluetooth or similar wireless technologyto activate the electrodes from the control unit 34.

IRCT (involuntary reflex cough test) testing will provide more reliabledata sampling of extubation failure risk than VC (voluntary cough) andespecially tracheostomies, which are the majority of prolonged intubatedpatients. There are many variables to the possible scenarios and theyrequire clinical judgment. It is possible to add a micro tube with atransducer that can plug into a processing device, such as the handheldprocessing device shown in FIGS. 21 and 22 and also Ng/Og or urologytubes as disclosed in commonly assigned patent application Ser. No.12/878,257 filed Sep. 9, 2010; Ser. No. 12/878,281 filed Sep. 9, 2010;and Ser. No. 12/878,316 filed Sep. 9, 2010, the disclosures which arehereby incorporated by reference in their entirety. These devices can beinserted via a percutaneous endoscopic gastrostomy tube (PEG) orJejunostomy (J-tube) and used to calculate the iRCT cough epoch valuesfor IAP responses to help determine extubation risk.

Many prolonged intubated patients are converted from Ng/Og tubes to PEGSor J tubes for feeding, and many intubated patients are changed totracheostomy tubes if it is a prolonged illness. Doctors continuallyattempt to determine what variables are required to extubate from thelarynx or decannulate safely from the larynx with the least risk ofreintubation. Some patents require this for post operative pneumoniaprevention. Patients that receive tracheostomies are usually sicker,weaker and have a higher risk of decannulating. If it fails, the patientis not in a good place with airway management, and stomas close quickly.Many tracheostomies are usually accompanied by tube feeding from Ng, PEGor J-tubes. The doctor or the clinician may have these tubes withpressure sensors for measurement already in place with the ability toplug into a processing device to measure, or have the ability to inserta transducer to measure through these tubes, which can be removed.

It should be understood that function of the lower esophageal (LES) andinternal urethral (IUS) sphincters has not been reported duringvoluntary and involuntary respiratory maneuvers. As noted before,prospective, barium videofluoroscopy study (BSV) of the LES wasperformed on four healthy adult males during voluntary cough (VC),laryngeal expiration reflex (LER), breath hold maneuvers and normalinspiration. One subject had fiberoptic pressure catheters placed in theLES and IUS, and EMG recording of the right T7-8 intercostals duringrespiration.

The BSV showed closure and relaxation of the LES corresponding to theinspiration and expiration of VC. The LES was patent during the LER.There was closure of the LES during the deep inspiration/breath holdevent. Pressure catheters in the LES and IUS showed increased pressureduring inspiration. These observations suggest that pulmonaryinspiration afferents elicit a patterned reflex motor response in theLES and IUS, referred to as the Inspiration Closure Reflex (ICR).

The respiratory cycle is modified in many ways and by many influencesthat also activate the expiratory muscles for respiration. When the lungwas distended by inspiration, pulmonary afferent impulses were conveyedto the brainstem via the Vagus nerve, and these afferent impulsesreflexively initiated expiration. When the lung was deflated, otherpulmonary afferent receptors were stimulated, and their impulses, alsoconveyed to the brainstem by the Vagus nerve, reflexively initiated thenext inspiration.

Voluntary cough (VC) and the laryngeal expiration reflex (LER) as aninvoluntary cough have been used for assessment of stress urinaryincontinence (SUI) in women and neurological airway protection inhumans. The urodynamic tracings from SUI clinical trials suggest thatthe inspiration during VC stimulates pulmonary afferent fibers that maydirectly activate closure of the internal urethral sphincter (IUS).

Commonly assigned U.S. application Ser. No. 13/354,100 filed Jan. 19,2012 by the same inventors, the disclosure which is hereby incorporatedby reference in its entirety, discloses a system and method ofdiagnosing acid reflux using an involuntary reflex cough test. In oneexample as disclosed, a nasogastric/orogastric (Ng/Og) device isinserted into the stomach and the involuntary reflex cough epochinduced. The intra-abdominal pressure and elevational reflux along theNg/Og device is measured. In an example, the functional status of thegastric valve is determined based on the measured intra-abdominalpressure and elevational reflux along the catheter.

Use of the involuntary reflex cough test with or without a voluntarycough test is also disclosed in commonly assigned U.S. patentapplication Ser. Nos. 11/608,316 filed Dec. 8, 2006; 11/550,125 filedOct. 17, 2006; 12/643,134 filed Dec. 21, 2009; 12/643,251 filed Dec. 21,2009; 12/878,257 filed Sep. 9, 2010; 12/878,281 filed Sep. 9, 2010; and12/878,316 filed Sep. 9, 2010; the disclosures which are all herebyincorporated by reference in their entirety. The '257, '281 and '316applications disclose oral-esophageal-gastric devices, some withesophageal cuffs and/or reflux measurement systems that can be used toassess GERD or determine stress urinary incontinence in some examplesusing the involuntary reflex cough tests alone or in combination withthe voluntary cough test.

There now follows a discussion of materials and testing method. The testincluded a prospective, barium swallow videofluoroscopy (BSV) study.Four normal, healthy male subjects participated in the BSV study. One ofthe subjects also underwent evaluation of the IUS and LES usingfiberoptic pressure catheters. After review of the study protocol,informed consent was obtained from all subjects. BSV studies of the LESwere performed using only thin barium solution in each subject. Thesubjects were standing for all BSV test maneuvers using a standinganterior-posterior view. Videofluoroscopic photomontages were capturedat three second intervals and analyzed for each maneuver.

For the VC, each subject swallowed a small cup of thin barium solutionfollowed immediately by a deep inspiration and a VC. The BSV captured,at the level of the LES, a photomontage of the barium flow during theVC.

The breath hold maneuver required the subject to perform a deepinspiration and breath hold followed immediately by swallowing a smallcup of thin barium solution. The BSV captured, at the level of the LES,a photomontage of the barium flow during the breath hold voluntarymaneuver. All of the photomontages were visually analyzed to determinethe relationship of the barium to the position of the LES and diaphragm.

The induced reflex cough test is a cough provocation test thatstimulates the laryngeal expiratory reflex (LER). The LER is a series ofexpiratory coughs (cough epoch) without a significant precedinginspiration. This LER cough epoch caused 5 coughs (C5) with an averageduration of 14.8 seconds. The following materials were used to performthe IRCT: a) vial containing a 20% solution of tartaric acid (NephronPharmaceutical, Inc; Orlando, Fla.); b) Pari LCD jet nebulizer (Bonn,Germany); c) oxygen flow meter; d) oxygen tank; and e) gloves and safetymask. The jet nebulizer was FDA approved for use in the U.S. and borethe CE Marking designating the manufacturer's compliance with CouncilDirective 93/68/EEC.

For the BSV study using the IRCT, the subject swallowed 50 ml. of thinbarium solution immediately followed by administration of the IRCT. TheBSV captured, at the level of the LES, a photomontage of the flow ofbarium, during the LER involuntary cough maneuver.

One subject also had both nasogastric and urethral fiberoptic,disposable catheters (#10 and #7 French catheters, respectively) withthe pressure sensors placed at the level of the LES and IUS,respectively. Electromyography (EMG) electrodes were placed at themid-axillary line of the T7-8 intercostal space and were used to confirmthe inspiratory activity of the intercostal muscles. The Lumax TS Prowas used to record LES and IUS pressures and EMG activity. Allurodynamic (UD) equipment and catheters used in this study were FDAapproved for use in the U.S. and bore the CE Marking designating themanufacturer's compliance with Council Directive 93/68/EEC.

The one subject, who participated in the catheter portion of the study,was positioned in a semi-recumbent lithotomy position (approximately 60degrees head up) such as using the structure shown in FIG. 3B as part ofa quantitative analysis of the LES and IUS activity during inspiratorymaneuvers. The subject performed deep and shallow breathing and breathhold maneuvers with simultaneous recording of LES and IUS pressures, andEMG intercostal inspiratory activity. The recordings were saved on theLumax TS Pro for analysis of pressure waves and EMG activity.

BSV followed immediately by VC showed transient interruption of bariumat the LES during inspiration, which released with expiration such asshown in the images in FIG. 5A. FIG. 5B shows a nerve conduction pathwaydiagram for the inspiration closure reflex. The BSV sequence in FIG. 5Ashows the barium swallow (left frame) followed immediately by deepinspiration (middle frame), which closes the LES and stops the flow ofbarium in the right frame. The expiration during voluntary coughreleases the LES and allows barium to enter the stomach. The schematicdiagram shows that the inspiration closure reflex (ICR) occurs with theactivation of pulmonary inspiratory afferent fibers and theirtermination in the nucleus tractus solitarius (NTS). Centrally, the NTSinfluences the activity of the phrenic nucleus, dorsal motor nucleus ofX and the sacral autonomic nucleus via descending pathways. This circuitregulates intrinsic sphincter tonicity during inspiration andexpiration. This result was reproducible in all subjects.

Deep inspiration and breath hold immediately followed by BSV showedcomplete interruption of barium at the LES during the entire breath holdevent as shown in FIGS. 6A and 6B. The photomontage or images in FIG. 6Alasted 23 seconds, and the flow of the barium was completely interruptedat the level of the LES during this entire voluntary maneuver. Thisresult was reproduced in all subjects.

FIG. 6B shows a nerve conduction circuit diagram for a barium swallowduring the breath-hold. The ICR is demonstrated in the BSV photomontageimages in FIG. 6A and the nerve conduction circuit diagram in FIG. 6B.The images depict the inspiration followed by swallowing barium. The LESclosed with deep inspiration and remains closed during the entireduration of breath hold (greater than 20 seconds), which appeared tohold the barium above the LES. The barium stayed above the LES untilexpiration.

In FIG. 7, at the region of the distal esophagus the diaphragm andproximal stomach were magnified using two consecutive images from abreath hold images as photomontages, which are separated by threeseconds. The arrows at the proximal esophagus indicate the level ofbarium solution. The arrowheads indicate the level of the proximalportion of the LES and the barium solution. The barium in the distalesophagus showed a distinctive V-shaped tapering of the esophagus thatsuggests a cuff-like closure of the LES. The dotted line in FIG. 7 inthe first image was placed above the diaphragm shadow, which was clearlyinferior to the distal tip of the barium solution. This result wasreproducible in all subjects.

BSV followed immediately by LER activation, using the IRCT, showed nointerruption of barium at the LES during expiratory coughs as shown inFIG. 8A. The LER images as photomontages had a 13-second durationwithout an inspiration. The failure of the LES to close during the LERcough epoch with continuous barium flow was reproducible in allsubjects.

FIGS. 8A and 8B show the Laryngeal Expiratory Reflex (LER). The BSVphotomontage in FIG. 8A was taken during an LER cough epoch and showedno closure of the LES. The LES appeared to be patent during the LERcough epoch, which allowed barium to flow into stomach. The primaryfunction of the LER is to clear the upper airway when food or fluidshave entered the laryngeal vestibule. The nerve conduction circuitdiagram in FIG. 8B shows that stimulation of laryngeal receptors, usingthe IRCT, initiates a series of 5 expiratory “coughs” withoutinspiration, i.e., the LER cough epoch. The nucleus tractus solitariusinfluences the phrenic nucleus and dorsal motor nucleus of X, whichinnervate the diaphragm and LES, respectively. During an LER coughepoch, the LES is patent and inspiration does not normally occur.

In the subject, who participated in the catheter portion of the study,the rapid closure and pressure elevation of the IUS after the initiationof each inspiration is shown in FIGS. 9B and 9B, which shows pressurerecordings of the IUS and LES synchronized with respiration.Simultaneous pressure recordings of the IUS (P_(IUS)) and LES (P_(LES))with respiratory EMG of the intercostal muscles at the T7-8 interspacedemonstrated the activity of the ICR during breathing. During slow, deepbreathing and rapid, shallow breathing, pressure waves indicated therespiratory rate and depth dependent variation.

FIG. 10 is a graph showing the latencies of the LES and IUS in relationto inspiration. The closure and pressure elevation of the IUS (P_(IUS))and LES (P_(LES)) occurred after the initiation of inspiration. Theseclosures (pressure waves) occur before the peak EMG activity, which isbefore the elevated IAP event in a voluntary respiratory maneuver.

Breath hold caused sustained pressure elevation in the LES (P_(LES)) andIUS (P_(IUS)) and corresponded to overlying voluntary contractions ofthe external urethral sphincter EUS (P_(EUS)) and pelvic floormusculature as shown in the graph of FIG. 11. During contractions of theEUS and pelvic floor muscles, the pressure of the LES (P_(LES)) remainedrelatively unchanged. There were no adverse events during this study.The graph in FIG. 11 shows breath hold with maintained pressureelevation in the LES and IUS. Breath hold caused sustained pressureelevation in the LES (P_(LES)) and IUS (P_(IUS)) and corresponded tooverlying voluntary contractions of the external urethral sphincter EUS(P_(EUS)) and pelvic floor musculature. During contractions of the EUSand pelvic floor muscles, the P_(LES) remained relatively unchanged.

Respiratory physiology. Bishop further identified expiratory muscleactivation as an extension and component of the Breuer reflex. Thestudies described above suggest that the respiratory maneuvers forcontrol of the closure and pressure of the IUS and LES duringinspiration and release with expiration appear to be coordinated andsynchronized with the rate and depth of inspiration. This is referred toas the Inspiration Closure Reflex as shown in FIGS. 5A and 5B.

In FIG. 8A, the BSV images as photomontages were taken during an LERcough epoch. The LES appeared to be patent during the LER cough epoch,which allowed barium to flow into stomach. The primary function of theLER is to clear the upper airway when food or fluids have entered thelaryngeal vestibule. The LER appears to be inhibitory for inspirationand breathing and the associated reflex motor activations, which preventclosure of the LES during the involuntary cough epoch. Prevention ofclosure of the LES, during involuntary elevated LAP, may cause reflux ofstomach contents in the presence of an incompetent gastric valve.

During slow, deep breathing and rapid, shallow breathing, pressure wavesindicated the respiratory rate and depth dependent variation (FIGS. 9Aand 98). Simultaneous pressure recordings of the IUS (P_(IUS)) and LES(P_(LES)) with respiratory EMG of the intercostal muscles at the T7-8interspace showed the influence of the Inspiration Closure Reflex (ICR).The amplitude of the catheter pressure waves was limited by thesensitivity of the fiberoptic transducers.

FIG. 10 shows an unexpected rapid closure and pressure elevation of theIUS (P_(IUS)) within one second, after the initiation of eachinspiration. This delay may be explained by the fast conduction (30-60m/sec) of the descending pathway in the spinal cord from the nucleustractus solitarius (NTS) via the lateral reticulospinal tract to theneurons in the sacral autonomic nucleus at S2-4 of the spinal cord. The25 cm long, unmyelinated, peripheral nerve component conducts at 0.5m/sec, and takes less than one second to close the IUS. The LES closurewas slightly delayed by approximately 1.5 seconds after the initiationof inspiration. This may be due to the different pathway from the NTS tothe dorsal motor nucleus of X and a long peripheral, unmyelinated vagalnerve (50 cm) to the LES. Both of these closures (pressure waves) occurbefore the peak EMG activity, which is before the elevatedintra-abdominal pressure (IAP) event in a voluntary respiratorymaneuver, e.g., voluntary cough or a Valsalva maneuver.

Control of the LES may be due to upper and lower esophageal reflexes anddiaphragmatic reflexes, i.e., a crural reflex. Some studies refer totransient relaxation or inhibition of the LES in association withswallowing obstructive sleep apnea, mechanical ventilation and anegative pressure body ventilator. In previous animal and human studies,respiration pressure “artifacts” in the LES and IUS were not noted orwere electronically filtered by manometry instruments. There may berespiratory influences on intrinsic sphincter function that have notbeen adequately evaluated.

In animal models that require cannulation for respiration and/orpositive mechanical ventilation, or in anesthetized animals or humans,the ICR may not have been observed. There has been some description of a“straining crural reflex” during the Valsalva maneuver that caused LESclosure by esophageal-diaphragmatic reflexes. In human studies with anegative pressure body ventilator (“iron lung”), pulmonary inspirationafferent fiber activity was abolished during negative pressureinspiration in healthy, non-anesthetized subjects. This type of negativeinspiration pressure ventilation and the absence of the subject'sinitiation of pulmonary inspiration afferent fibers abolished orsignificantly diminished manometric pressure of the LES duringinspiration.

During breath hold, the elevated pressures of the IUS and LES weresustained during the entire breath hold event. The volitionalcontractions of the EUS and pelvic floor muscles were observed on top ofthe IUS pressure wave, which were not present on the elevated LESpressure tracing (FIG. 11). A clinical example of the ICR function isshown in the urodynamic (UD) tracing of a series of voluntary andinvoluntary coughs in a female subject, who has moderate/severe SUI asshown in FIGS. 12A and 12B. The subject had an almost two-fold increasein average IAP with the VC, and each cough was preceded by a deepinspiration (inhalation). During the VC as shown in FIG. 12A, it isbelieved that the deep inspiration that preceded VC activated the ICRand closed the IUS and resulted in a false negative result for SUI inthis “moderate to severe” subject. During the involuntary cough epoch asshown in FIG. 12B, the IRCT UD tracing revealed multiple urinary leaksindicated by the marked vertical lines despite lower average IAPmeasurements compared to the VC.

These studies on IUS and LES activity, during respiratory events,suggest that if pulmonary inspiration afferent fibers are activated,these intrinsic sphincters close with every inspiration and release withevery expiration. During voluntary maneuvers such as VC, Valsalvamaneuver, or sneezing, these intrinsic sphincters release tonicity withexpiration. The degree of intrinsic sphincter closure appears to varywith the rate, depth or volitional modification of inspiration. The LESand IUS pressure responses seen in this study appear similar to the“respiration artifacts” in other studies. It is possible that the IUSclosure and pressure elevation related to inspiration could give astructural advantage at the neck of the urinary bladder to preventincontinence as shown in FIGS. 12A and 12B. During inspiration, it isalso possible that pulmonary inspiratory afferent fibers to the nucleustractus solitarius (NTS) may co-activate the phrenic nucleus, dorsalmotor nucleus of X (DMN) and the sacral autonomic nucleus as shown inFIG. 11. In FIG. 7, the LES closure and pressure elevation via theactivation of the DMN may coincide with simultaneous activation of thediaphragm. This simultaneous activation may prevent hiatal herniationduring elevated intra-abdominal pressure events such as Valsalvamaneuver or pushing during labor and delivery.

There were a small number of subjects in the study, but the findingswere method-dependent and reproduced in the four normal, healthysubjects for BSV and the one subject who had both the BSV and catheterstudies.

FIG. 13 is another nerve conduction circuit diagram showing theinspiration closure reflex. This diagram shows that the ICR occurs withthe activation of pulmonary inspiratory afferent fibers and theirtermination in the Nucleus Tractus Solitarius (NTS). Centrally, the NTSinfluences the activity of the phrenic nucleus, dorsal motor nucleus ofX and the sacral autonomic nucleus via descending pathways. This nerveconduction pathway circuit regulates intrinsic sphincter tonicity duringinspiration and expiration.

As noted before, there is a control unit 34 as shown, for example, inFIGS. 1-4 that is operative to correlate changes in the intra-abdominalpressure and duration with the depth of inspiration and processes thedata for direct microwire or indirect wireless transmission tostimulators of the smooth muscle of the internal urethral sphincter orstriated muscle for the external urethral sphincter or anal sphincter.Thus, there is either trans-urethral or trans-vaginal implantation ofmuscle stimulators to the IUS, EUS and/or AS. It is possible to test thesmooth muscle using intra-urethral electrodes or a pressure transducercatheter. One technique to test the maximal urethral closure pressure isto take the deepest breath possible. It is thus possible to treat stressincontinence with a stimulator and it is possible to address a deficitand identify and diagnose a deficit in the physiology by doing a maximalurethral closure pressure with inspiration and use an internal urethralsphincter transducer based on urodynamics.

There now follows detail of the disclosure from the incorporated byreference '841 patent application.

Research on the LES and gastric valve indicates that problems arise withthe gastric valve and there is a need for an available test to assessthe competency of the gastric valve. In accordance with a non-limitingexample, the involuntary maneuver, i.e., the involuntary cough test isemployed.

FIG. 14 is a flowchart showing a general sequence of steps that can beused for isolating the gastric valve and determine if the gastric valveis competent and functioning adequately in one example. The kit shown inFIG. 16A can include the components for use with this methodologydescribed relative to FIG. 14 and be used with the test system shown inFIG. 16B as explained below.

The sequence begins with a barium swallow (block 130) immediatelyfollowed by the involuntary reflex cough test, i.e., iRCT, such as byinhaling a chemo-irritant such as L-tartrate through a nebulizer in onenon-limiting example (block 132). The involuntary reflex cough testisolates the gastric valve from the LES. A determination is made usingvideo fluoroscopy, for example, if the reflux has occurred (block 134).If not, the gastric valve is competent and correctly functioning (block136). If reflux occurs, then the gastric valve is incompetent and ismalfunctioning since it is allowing the reflux (block 138). It ispossible to determine the severity of the reflux (block 140), forexample, by measuring the amount of reflux that occurs during theinvoluntary reflex cough epoch to estimate the severity of themalfunctioning gastric valve. This can be accomplished using enhancedfluoroscopy or using a Ng/Og catheter located at the LES or otherlocation as later described to determine the extent of reflux.

FIG. 15 is another flowchart showing a sequence of steps used forassessing the competency of the gastric valve and isolating the gastricvalve from the LES and also isolating the external urethral sphincterfrom the internal urethral sphincter to determine stress urinaryincontinence.

The process begins by inserting a urinary catheter in the patient with apressure sensor in one example and a sensor located at the internalurethral sphincter in an example. The Ng/Og tube may include at leastone sensor to be positioned at the LES and pH sensor at differentpositions. EMG pads can also be positioned at appropriate locations atthe mid-axillary line of the T7-8 internal space (block 150). This couldalso include the paraspinals. The bladder is filled such as with salinesolution (block 152). Barium or other contrast material is swallowed(block 154) and the involuntary reflex cough test induced (block 156).Two analysis paths are shown. A determination is made whether urineleakage occurred (block 158). If not, then the external urethralsphincter is competent and functioning adequately (block 160). If yes,then the external urethral sphincter leaked indicative of stress urinaryincontinence (SUI) (block 162). Some determination of the severity ofSUI or other problems can possibly be determined through analyzing theEMG results together with any intra-abdominal pressure that has beenrecorded during the involuntary reflex cough epoch. Reference is alsomade to the incorporated by reference applications for appropriate dataand analysis regarding same. A determination is also made whether refluxoccurred (block 164). If not, then the gastric valve is competent andfunctioning adequately (block 166). If yes, then the gastric valve isincompetent and is not functioning correctly (block 168). By using aNg/Og tube or advanced imaging of the contrast agent, e.g., BariumSulfate, it is possible to determine the severity of the reflux (block170) such as measuring the amount of reflux at the LES and otherlocations within the esophagus.

A patient kit for assessing the gastric valve in conjunction withfluoroscopy and the EUG can be provided and an example is shown in FIG.16A at 200. Items in this illustrated kit include:

1) Pneumoflex or USA Flex 20% tartaric acid in 3 ml unit dose vial 202;

2) 1000 ml Barium sulfate USP 204;

3) Ion Nebulizer or Crossfire Nebulizer 206;

4) Swivel adapter for nebulizer 208;

5) Protocol information sheet 210;

6) EMG pads 212;

7) Ng/Og tube or catheter 214; and

8) Urinary catheter 216.

The purpose of this kit 200 is to simplify the assessment of the gastricvalve functioning (and/or external urethral sphincter) using theinvoluntary maneuver, i.e., involuntary reflex cough test (iRCT) toincrease the intra-abdominal pressure to isolate the gastric valve whileinhibiting the LES and, in some examples, isolating the externalurethral sphincter. Evidence of gastric reflux can be observed directlyusing video fluoroscopy and evidence of SUI determined by isolating theexternal urethral sphincter to determine when there is urine leakage.

As shown in FIG. 16A, a handheld processing unit, such as describedlater relative to FIGS. 21 and 22, can be associated with the kit 200and includes catheter inputs, EMG and other inputs.

It is well known that the gastric valve allows food to enter the stomachbut prohibits reflux of gastric acid into the esophagus. As to thepatient kit 200, one aspect is the use of the swivel adapter 208 for thenebulizer such that when the patient is turned over, the nebulizerthrough use of the swivel adapter can be more readily used by a doctor.

There have been a number of previous tests to distinguish differenturinary incontinence problems including: 1) increasing theintra-abdominal pressure using a Valsalva maneuver; 2) having thepatient jump up and down; or 3) generating one or more strong voluntarycoughs. Through much clinical work, such as described herein and in thecopending and incorporated by reference patent applications identifiedabove, it has been determined that the involuntary reflex cough test(iRCT) activates the nucleus ambiguus, as compared to the voluntaryreflex cough test.

FIG. 16B shows a patient examining system 250 for imaging any contractagent that can be used to implement the methodology as described. Thepatient examining system includes a bed 252 supported on a swivel/pivot254 that is typically motor driven and allows the bed to be rotated andpivoted to place the patient in any predetermined position as inclinedor turned over, if necessary. A nebulizer 256 is supported on a swiveladapter 258 and rotatable into various positions. The nebulizer 256 canbe removable and could include a separate canister (shown by dottedlines at 215) or have nebulized medicine fed through a support arm 259associated with the nebulizer and swivel adapter 258. Imaging sensor 260can be positioned adjacent the patient for imaging barium or othercontrast agent the patient has swallowed (or been forcibly administereddepending on whether the patient is conscious). The processing unit 262includes various inputs as described relative to the processing unit218. The processing unit 262 can be a handheld processing unit or afixed computer connected to the imaging sensor and various cathetersinserted in the patient. The imaging sensor 260 in one example is afluoroscopic instrument configured to image the contrasting agent. Theimaging sensor is typically connected to the bed and moveable into aposition adjacent the patient to image the contrast agent as it flowsthrough the esophagus into the stomach during the involuntary reflexcough epoch. Data is transferred to the data processing unit where thedata is processed and the amount of reflux that occurs during theinvoluntary reflex cough epoch measured to estimate the severity of themalfunctioning gastric valve in one example or the extent of the gastricvalve adequate functioning. This could be accomplished, for example, bycomparing a plurality of photomontages taken by the image sensor duringthe involuntary reflex cough test.

This application is related to copending patent application entitled,“SYSTEM TO TREAT AT LEAST ONE OF THE URETHRAL AND ANAL SPHINCTERS,”which is filed on the same date and by the same assignee and inventors,the disclosure which is hereby incorporated by reference.

Many modifications and other embodiments of the invention will come tothe mind of one skilled in the art having the benefit of the teachingspresented in the foregoing descriptions and the associated drawings.Therefore, it is understood that the invention is not to be limited tothe specific embodiments disclosed, and that modifications andembodiments are intended to be included within the scope of the appendedclaims.

1. A method for diagnosing the function of intrinsic sphincters in apatient, comprising: inducing an involuntary reflex cough event withinthe patient contracting a muscle located at one of at least the urethraland anal sphincters during an inspiratory phase of respiration; anddiagnosing the function of the at least one of the urethral and analsphincters.
 2. The method according to claim 1, comprising detectingchanges in intra-abdominal pressure to determine the inspiratory phaseof respiration.
 3. The method according to claim 1, comprising detectingmovements of the ribs in a patient during inspiration and expiration fordetermining the inspiratory phase of respiration.
 4. The methodaccording to claim 3, comprising detecting movement of the ribs usingsensors placed at the anterior surface of the medial border of thecostal margin of ribs 8, 9 or
 10. 5. The method according to claim 1,comprising contracting a muscle located at one of the at least oneinternal or external urethral sphincters.
 6. The method according toclaim 5, comprising stimulating the muscle to contract by applying acurrent into the muscle.
 7. The method according to claim 6, comprisingimplanting electrodes on the muscle and applying a current to theelectrodes for stimulating the muscle to contract.
 8. The methodaccording to claim 7, comprising controlling muscle contraction bytransmitting control signals to the electrodes to initiate electricalstimulation from a control unit in communication with the electrodes. 9.The method according to claim 8, wherein the control unit is embedded inthe abdominal wall.
 10. The method according to claim 8, comprisingtransmitting control signals from the control unit to the electrodesthrough either microwires connecting the control unit and electrodes orwirelessly from the control unit to the electrodes.
 11. The methodaccording to claim 1, comprising contracting the muscle by activating amechanical mechanism on at least one of the urethral or anal sphincterto close the sphincter.
 12. A method for diagnosing the function ofintrinsic sphincters in a patient, comprising: inducing an involuntaryreflex cough event within a patient; applying a current to electrodesimplanted on the muscles of at least one of the urethral and analsphincters in response to control signals received from a control unitto contract the muscle during an inspiratory phase of respiration basedon inspiration/expiration endpoints of rib cage movement; and diagnosingthe function of the at least one of the urethral and anal sphincters.13. The method according to claim 12, comprising setting theinspiration/expiration endpoints by determining the point when a patienthas completely inhaled and exhaled and using those endpoints todetermine when the control unit should transmit the control signals. 14.The method according to claim 12, comprising embedding the controllerwithin the abdominal wall of the patient.
 15. The method according toclaim 12, comprising detecting changes in intra-abdominal pressure todetermine the inspiratory phase of respiration.
 16. The method accordingto claim 12, comprising detecting movements of the ribs in a patientduring inspiration and expiration to determine endpoints of rib cagemovement.
 17. The method according to claim 12, comprising detectingmovement of the ribs using sensors placed at the anterior surface of themedial border of the costal margin of ribs 8, 9 or
 10. 18. The methodaccording to claim 12, wherein the control unit is embedded in theabdominal wall.
 19. The method according to claim 12, comprisingtransmitting control signals from the control unit to the electrodesthrough either microwires connecting the control unit and electrodes orwirelessly from the control unit to the electrodes.
 20. The methodaccording to claim 12, comprising contracting the muscle by activating amechanical mechanism on at least one of the urethral or anal sphincterto close the sphincter.